Key Considerations When Choosing an IRT System for Clinical Trials

As a trial or drug supply manager for a clinical trial, selecting the best Interactive Response Technology (IRT) system is a pivotal decision in your planning process.
It’s not just a matter of the technology itself—the people and the processes involved in an IRT system must also be taken into account when evaluating prospective solutions, particularly for more complex studies.
In this article, we look at key factors you must consider when choosing IRT systems in clinical trials, putting the spotlight on trial requirements, deployment time for the system, and data quality to minimize data reconciliation effort.
IRT trial requirements
Can the IRT system you’re considering handle the unique demands of your clinical trial?
When considering if an IRT system is suitable for your trial, consider the following:
- Trial scope: How many sites are involved with the trial and what is the estimated number of participants involved; combined with other factors such as the number of participant dispensation visits, you need to know that the system can manage a large amount of data.
- Geographical spread: Will the trial span multiple countries with varying regulatory standards and a global supply chain?
- Trial complexity: Does the protocol design include any randomization, participant treatment, trial supply, or operational complexities? Do you have concerns about the optimal way to implement the trial design?
- Future requirements: Does the trial include the possibility of protocol design adaptations or supply chain changes? Can the IRT include up-front flexibility to manage design or supply changes?
IRT system functionality
While preferences may guide your choice, functionality is often dictated by necessity. Here are some essential features to look for:
- Data quality: Ensure the system is designed with first-time data quality in mind to minimize data reconciliation effort. IRT systems should allow Sites to make approved data changes, with audit trails and integration of data changes with other eClinical systems.
- Alerts and notifications: IRT systems also typically provide alerts and notifications. These are important because they give users immediate confirmation of their actions and advance warning that they need to take action.
- Data access: Many IRT systems offer custom reporting, including dashboards and data visualization to improve engagement and user experience.
- Customization: Many IRT systems offer a high level of customization, allowing the system to be tailored to meet novel and complex needs.
- Data security: Ensure the system includes robust safeguards to protect sensitive information and restrict access to authorized users only.
- Integration: Can the IRT seamlessly integrate with any 3rd party systems needed e.g., to receive unblinding lab data.
IRT system deployment time
IRT system deployment time—the period in which the system will be set up and fully implemented—will vary according to the scope of the clinical trial.
Common industry estimates of the average time to build, validate, and release an IRT solution are from 6 to 12 weeks. A trial’s requirements, whether standard or complex account for the difference in deployment time.
This could be affected by a variety of factors, such as the complexity of the trial design, system customization needs, the extent of integration with other systems, and the time needed for testing and validation before the system goes live.
If your clinical trial has a tight timeline, you may want to consider IRT systems with faster deployment capabilities, such as those with pre-configured templates for common trial types or a more streamlined setup process. Large-scale or multinational trials with more complex needs are likely to require a longer deployment time to ensure the system works seamlessly across multiple sites and countries.
IRT compliance
Finally, it’s vital that an IRT vendor can comply with relevant regulations for clinical trials, including those from the ICH’s Good Clinical Practice (GCP) to the U.S. FDA’s 21 CFR Part 11, to ISO certifications in technology and risk management. Your IRT vendor should comply with relevant regulations including user identity management, data integrity, system validation, data protection & IT security which set out key required protections such as audit trail security, automated time stamping, and user identity verification.
In the process of selecting an IRT vendor for your clinical trial?
Perceptive eClinical’s IRT/Randomization and Trial Supply Management System (RTSM) system is proven to improve data quality and reduce error risk in clinical trials.
Our system offers both control and adaptability, allowing immediate changes to RTSM design and helping both trial investigators and sponsors make informed decisions throughout the trial process.
Contact a Perceptive eClinical Solutions Specialist today, or click here to learn more about our IRT/RTSM solutions.